Data from the WAVE I study, presented at a late-breaking trial session at EuroPCR (21-24 May, Paris, France), showed that patients treated with Kona Medical’s Surround Sound renal denervation system had no device-related serious adverse events, and experienced a 22mmHg drop in systolic blood pressure and a 9mmHg drop in diastolic blood pressure at three months (N=24)
According to a company press release, WAVE I is a first-in-man study evaluating the safety and efficacy of Kona Medical’s Surround Sound renal denervation system for the treatment of resistant hypertension. Unlike other renal denervation methods, which rely on a catheter emitting energy through the wall of the renal artery, Kona’s system delivers ultrasound energy to the nerves from outside the body. This targeted energy “surrounds” the artery and treats the nerves located in the vicinity of the vessel.
The study showed that at three months, patients had no device-related serious adverse events and experienced a 22mmHg drop in systolic blood pressure and 9mmHg drop in diastolic blood pressure at three months (N=24). In those patients who had reached six months follow up (N=14) there was a 29mmHg drop in systolic blood pressure and 9mmHg drop in diastolic blood pressure.
On average, study participants had a baseline blood pressure of 190 mmHg systolic and 100 mmHg diastolic and were taking an average of 4.5 anti-hypertension medications. Eleven of 14 participants (78%) reaching the six month efficacy endpoint had a clinically significant drop in systolic blood pressure of 10 mmHg or more. Results from norepinephrine spillover studies indicate strong evidence of sympathetic denervation. There were no adverse findings in the subjects’ renal vasculature based on six-week angiogram (n=9) and 24 week MRI (n=14).
Currently, the clinical sites are enrolling and treating participants in a follow-on study, WAVE II, which uses an optimised treatment protocol that reduces therapy delivery time from approximately 12 minutes per side (in WAVE I) to under three minutes. The study sponsor, Kona Medical, also has announced plans to initiate the WAVE III study, which will evaluate the safety and efficacy of a fully external (non-invasive) version of its ultrasound-based therapy.
Study presenter Robert Whitbournm, of St. Vincent’s Hospital in Melbourne, Australia, said: The results from this initial study of external ultrasound for renal denervation are very promising. Blood pressure reduction in this very severe hypertensive cohort grows over time. We’ve also seen that the ultrasound energy leads to effective denervation without any discernible effect on the renal artery. While more studies are required to confirm these results, external ultrasound appears to have strong potential as an alternative to catheter based energy delivery for patients with hypertension.”